Orthosis to Improve Trunk Control in Infants Age 6-18 Months

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06027580
• Collaborator: SPIO (Other)
• Enrollment: 30
• Anticipated Duration (Months): 23

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

Detailed Description

This study will observe the difference in outcomes between two courses of standard clinical care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will self-select that standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
SPIO group Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis	Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis; SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
Control group Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone

Outcome Measures

Primary Outcome Measures

1. Change in head and trunk position from centerline at baseline, 3-months and 6-months. [Through study completion, an average of 2 years]

2. Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale. [Through study completion, an average of 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 18 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone

• No previous use of SPIO® or similar Lycra/compression garments

• Assessed by provider as likely to benefit from use of compression garment

Exclusion Criteria:

• Non-English speaking

• Inability for family to bring study subject to assessments

• Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period

• Botulinum toxin injections within 3 months, or during study participation

• Having prior orthopedic or neurosurgery surgeries within one year

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical College of Wisconsin
• SPIO

Investigators

• Principal Investigator: Stacy Stibb, DO, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stacy Stibb, Assistant Professor, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT06027580
• Other Study ID Numbers: PRO00048530
• First Posted: Sep 7, 2023
• Last Update Posted: Sep 7, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stacy Stibb, Assistant Professor, Medical College of Wisconsin: abnormal muscle tone; cerebral palsy; hypotonia; muscle tone; spasticity
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

No Results Posted as of Sep 7, 2023